期刊名称：International Journal of Software Engineering and Its Applications
印刷版ISSN：1738-9984
出版年度：2014
卷号：8
期号：1
页码：371-376
DOI：10.14257/ijseia.2014.8.1.32
出版社：SERSC
摘要：R&D software development project has different goals and different organization structure. The importance of medical device software is increasing as the quality of medical device. But the quality capability of medical device specific SW R&D project members is not mature so the CMM-I and SPICE framework is not appropriate. In this paper, we suggest quality assessment framework for medical device software process in R&D project. We identify the critical features of medical device software1) safety 2) standardization 3) continuing change. With these feature, we suggested quality assessment scheme and evaluation procedure.
关键词：SW R&D project; quality assessment framework; medical software
